CTIS2024-511793-71-00RecruitingPhase 1
A Phase 1/2 Study of the Highly Selective ROS1 Inhibitor NVL-520 in Patients with Advanced NSCLC and Other Solid Tumors (ARROS-1) - NVL-520
uvalent Inc.0 sites249 target enrollmentStarted: March 18, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 249
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 0 to 65+ (—)
- Sex
- All
Inclusion Criteria
- •1. Age =18 years a. Phase 2 Cohort 2e only: Age =12 years and weighing > 40 kg. 2. Disease criteria a. Phase 1: Histologically or cytologically confirmed locally advanced or metastatic solid tumor with documented ROS1 rearrangement. b. Cohorts 2a, 2b, 2c and 2d: Histologically or cytologically confirmed locally advanced or metastatic ROS1 rearrangement. c. Cohort 2e: Histologically or cytologically confirmed locally advanced or metastatic solid tumor (including NSCLC not eligible for Cohorts 2a-2d) with ROS1 rearrangement. 3. Prior anticancer treatment 4. Phase 1: Must have evaluable disease (target or nontarget) according to RECIST 1.1. Phase 2: Must have measurable disease, defined as =1 radiologically measurable target lesion according to RECIST 1.1. 5. Pre-treatment tumor tissue. Please refer to the protocol for further criteria.
Exclusion Criteria
- •Patients meeting any of the following criteria will be excluded from the study: 1. Patient’s cancer has a known oncogenic driver alteration other than ROS1. 2. Known allergy/hypersensitivity to excipients of NVL-520. 3. Major surgery within 4 weeks of first dose of study drug. 4. Ongoing or recent anticancer therapy. 5. Ongoing or recent radiation therapy within the following timeframe prior to first dose of study drug. Please refer to the protocol for further criteria.
Investigators
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